Packaging of catheter products

ABSTRACT

According to one aspect of the invention, a medical package is provided which includes a housing, and a catheter product. The housing defines an enclosure which is sealed against ingress of contaminants. The housing has at least a first part and a second part which is movable relative to the first part to open the enclosure. At least one of the parts has a plurality of pores through which a sterilization fluid can enter the enclosure, but which substantially prevent entry of contaminants into the enclosure. The catheter product includes a body, and a vascular access member. The vascular access member has a first end and a second, vascular entry end. The first end is secured to the body and the second end is located distant from the body. The catheter product is located entirely within the enclosure. The catheter product is secured in position to the housing. The catheter product is removed from the housing after the second part is moved relative to the first part to open the enclosure.

This application is a divisional application of the U.S. patentapplication Ser. No. 09/267,148, filed Mar. 11, 1999, now U.S. Pat. No.6,186,325.

BACKGROUND OF THE INVENTION

1). Field of the Invention

This invention relates to packaging of catheter products.

2). Discussion of Related Art

Catheter products are increasingly used for gaining entry into internaltarget sites, for example for gaining entry into a lumen or othervascular of a person, and for passing diagnostic, therapeutic or otheragents into or removing fluids from the internal target sites.

A catheter product of this kind usually includes a body, and an elongatevascular access member having a first end secured to the body and asecond end located distant from the body. The second end is insertedinto a lumen or other vascular. Many catheter products have needleslocated in their vascular access members, the needles having sharp tipswhich are used for piercing a required area for purposes of gainingentry. On other catheter products the vascular access members themselvesare needles which have second ends which are sharpened for purposes ofgaining entry. Once entry is gained into a required internal targetsite, fluids can be passed through the vascular access member and thebody to or from the internal target sites.

A catheter product is usually packaged by first inserting the vascularaccess member thereof through an opening in a sheath, followed by thebody thereof. The body is then secured to the sheath so that thecatheter product is located in a stationary position relative to sheathwith the second end of the vascular access member located distant froman inner wall of the sheath. The sheath then provides the necessarystructure to protect the vascular access member.

Once the catheter product is secured to the sheath, a portion of thebody of the catheter product still protrudes from the opening in thesheath, thus potentially exposing the portion of the body protrudingfrom the opening in the sheath to contamination. An interface betweenthe body and the sheath is also usually not of the kind which preventsingress of contaminants into that the sheath, thus potentially exposingthe remainder of the catheter product, including the vascular accessmember, to contamination.

To prevent contamination, the sheath and the catheter product aresubsequently loosely located within conventional blister packaging. Theblister packaging provides an enclosure which is sealed against ingressof contaminants and prevents contamination of the sheath and catheterproduct. The catheter product, in effect, therefore has to be packagedtwice, once to provide the required structural integrity to protect thevascular access member, and once more to prevent contamination.

SUMMARY OF THE INVENTION

According to one aspect of the invention, a medical package is providedwhich includes a housing, and a catheter product. The housing defines anenclosure which is sealed against ingress of contaminants. The housinghas at least a first part and a second part which is movable relative tothe first part to open the enclosure. At least one of the parts has aplurality of pores through which a sterilization fluid can enter theenclosure, but which substantially prevent entry of contaminants intothe enclosure. The catheter product includes a body, and a vascularaccess member. The vascular access member has a first end and a second,vascular entry end. The first end is secured to the body and the secondend is located distant from the body. The catheter product is locatedentirely within the enclosure. The catheter product is secured inposition to the housing. The catheter product is removed from thehousing after the second part is moved relative to the first part toopen the enclosure.

The first part may be a hollow sheath with an opening providing accessinto the sheath. The catheter product may be at least partially locatedwithin the sheath and be secured to the sheath inside the sheath. Thesecond part maybe a lid which closes the opening.

A lid may be attached to a periphery of the opening and the attachmentbetween the lid and the periphery of the opening may be at leastpartially breakable.

The enclosure, formed by the sheath, may be relatively large in a firstarea near the opening and relatively small in a second area on a side ofthe first area opposing the opening. The body may be secured to thesheath in the first area, and the elongate needle member may be at leastpartially located in the second area.

The sheath may have a retaining formation extending from an innersurface thereof, and the body may have an engaging formation whichengages with the retaining formation to support the catheter product inposition.

The retaining formation may include first and second projections with agap defined between them. At least one of the projections may be movableto the extent that it can give way under a force created by the engagingformation when the catheter product is inserted into the sheath, and atleast partially return to its original position so as to lock theengaging formation in the gap.

The sheath may at least partially be made of a flexible material. Theretaining formation may move away from the engaging formation when thesheath is flexed, thereby disengaging the engaging formation from theretaining formation so as to allow for removal of the catheter productfrom the sheath.

The medical package may include finger tabs on opposing side of thepackage sheath which, when contacted by two respective fingers on a handof a person, and are moved relative to one another by the fingers, maycause movement of the retaining formation away from the engagingformation and disengagement of the engaging formation from the retainingformation.

The retaining formation may extend in a first selected direction fromthe inner surface. When the finger tabs are moved relative to oneanother, the sheath may be squeezed together transversely to the firstselected direction, causing the retaining formation to move away fromthe engaging formation in a second selected direction, opposing thefirst selected direction, and disengagement of the engaging formationfrom the retaining formation.

The medical package may include flange portions extending from thesheath, and the finger tabs may be located on the flange portions.

The flange portions may pivot about first portions of the sheath andcompress second portions of the sheath towards one another to causeelongation of at least part of the sheath in the second selecteddirection.

At least a first of the finger tabs may pivot about a first portion ofthe sheath, and the retaining formation may be located on a secondportion of the sheath, and a side of the first portion approximatelyopposing the first finger tab, so that, when the first finger tab pivotsabout the first portion in a first pivoting direction, the retainingformation also pivots in the first pivoting direction about the firstportion away from the engaging formation.

The sheath may include an additional retaining formation which engageswith a retaining formation of the sheath. A second of the finger tabsmay pivot about a third portion of the sheath. The additional retainingformation may be located on a fourth portion of the sheath on a side ofthe third portion approximately opposing the second finger tabs so that,when the second finger tab pivots about the third portion in a secondpivoting direction, opposing the first pivoting direction, theadditional retaining formation also pivots in the second direction awayfrom the additional engaging formation.

The sheath may have a hinge portion between the retaining formationswhich, when the first finger tab pivots in the first pivoting directionand the second finger tab pivots in the second pivoting direction,assists in increasing an amount of rotation of the retaining formationsrelative to one another, resulting in more movement of the respectiveretaining formations away from the respective engaging formations.

The hinge portion may be formed so as to create a stress concentrationwhich causes more flexing of the sheath.

The hinge portion may be a narrowing in the sheath.

The sheath may have at least first and second components. When the lidis at least partially removed, the second component may be movablerelative to the first component to allow for better access to themedical product.

The retaining formation may be located on an inner wall of the sheath,and the body may have an engaging formation which engages with the firstcomponent. When the second component is moved relative to the firstcomponent to allow for better access to the medical product, theengaging formation may be engaged with the retaining formation.

The second component may hinge relative to the first component.

The sheath may have at least a third component which hinges relative tothe first component to allow for better access to the medical product.

The opening may have at least two finger wells, on different sides ofthe catheter product. Fingers on a hand of a person may be insertableinto the finger wells. The finger wells may be open towards the catheterproduct to allow for gripping of the catheter product and subsequentremoval of the catheter product from the sheath.

The sheath may have first and second opposed wall portions having edgeswhich partially define the opening, and the lid closing off the opening,wherein the edges are shaped so that, when the lid is at least partiallymoved to open the enclosure, there is a line of sight through the sheathbetween the wall portions of the sheath, the line of sight being atleast partially blocked by the catheter product.

The opening may be formed so that, when the lid is at least partiallymoved to open the enclosure, a portion of the medical product may beexposed when viewed in a direction at right angles to a center line ofthe medical product.

The second end is preferably displaced from an inner wall of thehousing.

A sharp tip is preferably located at the second end.

The vascular access member is preferably a needle and the second end isa sharp tip of the needle. The medical package may further include acatheter assembly which includes a hollow hub and a catheter. Thecatheter has a first end secured to the hub and a second end locateddistant from the hub. The hub and catheter are located over the needlewith the catheter located on a side of the hub opposing the body. Thehousing may have a shelf on an inner surface thereof which supports thehub on a surface thereof opposing the body.

The invention also provides a medical package which includes a housingand a catheter product. The housing defines an enclosure which is sealedagainst ingress of contaminants. The housing has a hollow elongatesheath with an end having an opening into the sheath. The lid closes theopening and seals with a periphery of the opening. The catheter productincludes a body, and a vascular access member. The vascular accessmember has a first end and a second, vascular entry end. The first endis secured to the body and the second end is located distant from thebody. The catheter product is located entirely within the sheath.

The invention also provides a method of packaging a catheter product.The catheter product is located within a housing. The housing defines anenclosure which is sealed against ingress of contaminants and has atleast one part having a plurality of pores through which a sterilizationfluid can enter the enclosure, but which substantially prevent entry ofcontaminants into the enclosure. The medical product is located entirelywithin the enclosure. The medical product has a body secured in positionto the housing, and a vascular access member having a first end andsecond, vascular entry end. The first end is secured to the body and thesecond end is located distant from the body in a position which isdisplaced from an inner wall of the housing.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is further described by way of examples with reference tothe accompanying drawings wherein:

FIG. 1 is a partially sectioned perspective view of a medical packageaccording to one embodiment of the invention;

FIG. 2 is a cross-sectional side view of the medical package of FIG. 1;

FIG. 3 is a cross-sectional view on 3—3 in FIG. 2;

FIG. 4 is a view similar to FIG. 3 illustrating release of a catheterproduct from a sheath of the medical package;

FIG. 5 is a perspective view of a housing of a medical package accordingto an alternative embodiment of the invention;

FIG. 6 is a cross-sectional end view of the housing of FIG. 5, furtherillustrating a catheter product secured within the housing;

FIG. 7 is a perspective view illustrating a part of a medical packageaccording to a further embodiment of the invention;

FIG. 8 is a view similar to FIG. 7 after a housing of the medicalpackage is broken open;

FIG. 9 is a perspective view of the part of a medical package accordingto yet a further embodiment of the invention;

FIG. 10 is a cross-sectional side view on 10—10 in FIG. 9;

FIG. 11 is a cross-sectional side view on 11—11 in FIG. 9;

FIG. 12 is a cross-sectional side view of a medical package according toyet a further embodiment of the invention; and

FIG. 13 is a cross-sectional side view of the medical package of FIG. 7.

DETAILED DESCRIPTION OF THE INVENTION

A number of embodiments of a medical package according to the inventionare described. In each case, the medical package includes a housingdefining an enclosure which is sealed against an ingress ofcontaminants, and a catheter product. The housing includes an elongatesheath with an opening in an end providing access into the sheath, and alid which closes the opening. The lid is made of a breathable materialwhich allows for a sterilization fluid to enter the enclosure, but whichprevents contaminants from entering the enclosure. The catheter productis of the kind which includes a body, and a needle having one endsecured to the body and an opposing, sharp vascular entry end. Thecatheter product is located in a stationary position relative to thesheath by mounting the body releasably to the sheath. The sheath soprovides the necessary structural rigidity to prevent damage to theentire catheter product, and forms part of a housing which encloses thecatheter product so that the catheter product is prevented from beingcontaminated.

FIG. 1 of the accompanying drawings illustrates a medical package 14according to one embodiment of the invention. The medical package 14includes a housing 16, and a catheter product 18 located within thehousing 16.

FIG. 2 illustrates the medical package 14 in cross-sectional detail. Thehousing 16 includes an elongate hollow sheath 20 and a lid 22.

The sheath 20 has an opening 24 at the upper end thereof which providesaccess into the sheath 20. The sheath 20 is relatively large in a firstarea 28 near the opening 24, and relatively small in a second area 30 ona side of the first area 28 opposing the opening 24.

The sheath 20 has a plurality of retaining formations 32 extending froman inner surface thereof within the first area 28. Each retainingformation 32 includes first and second projections, 34 and 36respectively, with a gap 38 defined between the first and secondprojections 34 and 36.

The lid 22 is made of a breathable material which is sold under the name“TYVEK” by Dupont. The breathable material typically has pores which areabout 0.2 microns in diameter.

The catheter product 18 includes a body 40, an elongate vascular accessmember or needle 42, and a catheter assembly 43.

The body 40 has an annular engaging formation 44 extending from an outersurface thereof. The needle 42 has a first end 46 and a second, vascularentry end 48. The first end 46 is secured to the body 40 and second end48 is located distant from the body.

The catheter assembly 43 includes a hub 50, and a catheter 52. The firstend 54 of the catheter 52 is secured to the hub 50 and a second,opposing end 56 of the catheter 52 is located distant from the hub 50.The second end 45 of the needle 42 is inserted through the hub 50, andfrom the hub 50 through the catheter 52 until the second end 48 of theneedle 42 protrudes out of the second end 56 of the catheter 52.

The second end 48 of the needle 42 has a sharp tip which may be used forpiercing a vascular such as a vein or an artery. The catheter 52 and theneedle 42 are then inserted into the vascular. Fluid within the vascularpasses through the needle 42 into the body 40. The body 40 is usuallytransparent so that the fluid is visible through the body 40. The needle42 is then removed from the catheter 52 and another device such as asyringe or a pipe of a drip is connected to the hub 50. Fluids can bepassed between the other device and the vascular through the hub 50 andthe catheter 52.

The medical package 14 is assembled by first inserting the catheterproduct 18 through the opening 24 into the sheath 20. The needle 42 isinserted first into the sheath 20, followed by the body 40. The firstprojections 34 are spaced relative to one another more closely than anouter diameter of the engaging formation 44 so that the engagingformation 44 is brought into contact with sloped upper surfaces 58 ofthe first projections 34. When the catheter product 18 is furtherinserted into the sheath 20, the engaging formation 44 creates outwardforces acting on the sloped upper surfaces 58.

The sheath 20 is made of a flexible material such as polypropylene ornylon and, due to its materials and construction, flexes under the forcecreated by the engaging formation 44 so that the spacing between thefirst projections 34 widens. Once the spacing between the firstprojections 34 widens, the engaging formation 44 passes through thefirst projections 34 and comes to rest against the second projections36. Due to the flexibility of the sheath 20, the first projections 34then return to their original positions in a snapping action. Once thefirst projections 34 have returned to their original positions, theengaging formation 44 is locked within the gaps 38.

By locking the engaging formation 44 within the gaps 38, the catheterproduct 18 is mounted to the sheath 20 and supported in a stationaryposition relative to the sheath 20. The catheter product 18 is entirelylocated in the sheath 20 and the sheath 20 is sufficiently strong toprotect the catheter product 18. The body 40 is located in the firstarea 28 of the sheath 20. The needle 42 is almost entirely located inthe second area 30 of the sheath 20 with the second end 48 and the sharptip 56 both displaced from an inner wall of the sheath 20.

A retaining shelf 60 is located on an inner sheath 20. The hub 50 has asurface on opposing sides thereof and the body 30 which rests on theshelf 60. The shelf 60 so prevents the catheter assembly 43 from movingoff the needle 42.

The lid 22 is then positioned so that it closes off the opening 24 andis then heated so that a periphery thereof seals circumferentially on aperiphery of the opening 24 and is attached to a periphery of theopening 24. The sheath 20 and the lid 22 so jointly define an enclosure62 which is sealed against ingress of contaminants.

Because of the porous nature of the lid 22, a sterilization fluid suchas ethylene oxide gas may be introduced into the enclosure 62 so thatthe confines of the enclosure 62 may be sterilized. The pores within thelid 22 are, however, generally too small for contaminants ormicroorganisms to pass through so that the confines of the enclosure 62remain sterile.

The housing 16 of FIG. 1 and FIG. 2 provides a rigid and sturdyenclosure which entirely encloses the catheter product 18 and supportsthe catheter product 18. There is therefore no need for additionalpackaging such as blister packaging to seal the housing 16 againstingress of contaminants. The medical package 14 can thus be provided toa user substantially in the form shown in FIG. 1 and FIG. 2.

The lid 22 has a tab 64 which can be pulled so that the attachmentbetween the periphery of the lid 22 and the periphery of the opening 24is broken. The lid 22 can so be removed from the sheath 20 so that theenclosure 62 is opened to provide access to the catheter product 18.

Removal of the catheter product 18 from the sheath 20 is now discussedwith reference to FIG. 3 and FIG. 4.

FIG. 3 illustrates the medical package 14 in cross section on 3—3 inFIG. 2. The sheath 20 includes strengthening first portions, or ribs 66on opposing sides thereof. The sheath 20 extends from each rib 66 torespective second portions 68 thereof. Third, flange portions 70 extendfrom the second portions 68 away from the sheath 20. The flange portions70 are substantially parallel to one another and finger tabs 72 arelocated on outer surfaces of the flange portions 70.

The sheath 20 includes fourth portions 74 extending from the secondportions 68 and coming together at one of the first projections 34A (ofone of the retaining formations 32). The first projection 34A extendsfrom an inner surface of the sheath 20 in a first selected direction 76to engage with the catheter product 18.

Fifth portions 78 of the sheath 20 extend from the ribs 66 to more ofthe first projections 34B and 34C. The respective first projections 34Band 34C are located on sides of the ribs 66 approximately opposing thefinger tabs 72. The first projections 34B and 34C also extend from aninner surface of the sheath 20 to engage with the catheter product 18.

A sixth portion 80 of the sheath 20 extends from the first projection34B to the first projection 34C. The sixth portion 80 includes a hingeportion 82 located about halfway between the first projection 34B andthe first projection 34C. The hinge portion 82 is a narrowing in thesixth portion 80.

To remove the catheter product 18 from the sheath 20, the medicalpackage 14 is first inverted so that the opening 24 is at the bottom.The finger tabs 72 are spaced from one another so that a person mayeasily engage first and second fingers on one hand, for example a thumband a forefinger, with the respective finger tabs 72.

As shown in FIG. 4, the person may then squeeze the flange portions 70towards one another in a direction transversely to the first selecteddirection 76. The flange portions 70 pivot about the ribs 66 in firstand second pivoting directions 84A and 84B respectively, therebycompressing the second portions 68 towards one another. The secondportions 68 act on the fourth portions 74 to cause flexing andelongation of the sheath 20 in a second selected direction 86 opposingthe first selected direction 76. The elongation, or flexing of thesheath 20 in the second selected direction 86 results in movement of thefirst projection 34A in the second selected direction 86 away from thecatheter product 18, and disengagement thereof from the catheter product18.

The fifth portions 78 pivot together with the flange portions 70 in thefirst and second pivoting directions 84A and 84B so that the firstprojections 34B and 34C also move away from the catheter product 18, inthird and fourth directions 88 and 90 respectively, when the flangeportions 70 are squeezed together, resulting in disengagement of thefirst projections 34B and 34C from the catheter product 18.

Movement of the first projections 34B and 34C in the third and fourthdirections 88 and 90 cause movement of the sixth portion 80 towards thecatheter product 18, or shortening of the sheath 20 in a fifth direction92. A stress concentration is created within the hinge portion 82 whichassists in bending of the sixth portion 80 in the region of the hingeportion 82. Assisted bending of the sixth portion 80 in region of thehinge portion 82 results in more rotation, or “hinging”, of the firstprojection 34B in a direction 94 about the hinge portion 82, and of thefirst projection 34C in a direction 96 about the hinge portion 82.Because of more hinging of the first projections 34B and 34C about thehinge portion 82, movement of the first projections 34B and 34C in thethird and fourth directions 88 and 90 is enhanced and disengagement ofthe first projections 34B and 34C from the catheter product 18 isassisted.

Once the first projections 34A, 34B, and 34C are disengaged, thecatheter product 18 simply drops out of the sheath 20 through theopening 24. Referring again to FIG. 2, the sheath 20 flexes at the firstarea 28 but not in the second area 30. There is thus no danger ofdamaging the needle 42 when the sheath is flexed to remove the catheterproduct 18. The wall thickness of the sheath in the second area 30 maybe made thicker than the wall thickness in the first area 28 so that thesheath can flex sufficiently in the first area 28, but add extraprotection for the needle in the second area 30.

It can be seen from the aforegoing description that the catheter product18 is entirely located within the sheath 20 even after the lid 22 isremoved, thus substantially reducing risk of contamination of thecatheter product 18 even after the lid 22 is removed. The catheterproduct 18 is then removed from the sheath 20 without the need fortouching the catheter product 18 and therefore with substantiallyreduced risk of contamination of the catheter product 18. By contrast,the embodiments herein after described all make provision foraccessibility of catheter products so that the catheter products can bemanually removed. In the descriptions of the embodiments which follow,for purposes of efficacy, not all details thereof are described anddiscussed in detail. Instead, the description of each of the embodimentswhich follow primarily indicates differences between the specificembodiment described and an embodiment or embodiments which have beendescribed previously. Unless specifically stated otherwise or unless itcan be inferred, therefore, it can be assumed that the details ofsubsequent embodiments are the same as details of embodiments which havebeen described previously. In particular, the catheter product of theembodiment wherein after described is the same as the catheter product18 of FIG. 1 and in each case includes a catheter assembly such as thecatheter assembly 43 of FIG. 1. The catheter assemblies are supported ina manner similar to a manner in which the shelf 60 support the catheterassembly 43 as illustrated in FIG. 2.

FIG. 5 illustrates a housing 110 of a medical package according to onealternative embodiment of the invention. The housing 110 includes asheath 112 and a lid 114.

The sheath 112 includes first, second, third, and fourth walls 116, 118,120, and 122 respectively. The first and second walls 116 and 118 opposeone another and the third and fourth walls 120 and 122 oppose oneanother. Upper peripheries of the walls 116, 118, 120, and 122 define aperiphery of an opening 124 into the sheath 112.

The lid 114 may be of the kind hereinbefore described with reference toFIG. 1 and FIG. 2 and is secured over the opening 124 in a similarmanner. Upper peripheries of the first and second walls 116 and 118 arecurved so that, when the lid 114 is removed, there is a line of sight ina direction 126 through the sheath 112 between upper portions of thewalls 116 and 118.

FIG. 6 shows the sheath 112 in cross section when viewed in thedirection 126 of FIG. 5. A catheter product 128 is mounted between thefirst and second walls 116 and 118 in a manner similar to the manner inwhich the catheter product 18 of FIG. 1 and FIG. 2 is mounted to thesheath 20. The line of sight through of the sheath 112 between upperportions of the first and second walls 116 and 118 is blocked by aportion of a body 130 of the catheter product 128, while the remainderof the body 130 and a needle 132 of the catheter product 128 areentirely located within the sheath 112. An upper portion of the body 130thus protrudes above a portion of an upper periphery of the opening 124.The upper portion of the body 130 is therefore accessible and can begripped between two fingers. The catheter product 128 can then be pulledfrom the sheath 112 with retaining formations 134 giving way under aforce created when the catheter product 128 is pulled out of the sheath112.

When the sheath 112, the catheter product 128 and the lid 114 areassembled, a medical package is provided which is assembled in the samemanner, made of the same materials, and is the same as the medicalpackage 14 of FIG. 1 and FIG. 2 in all other respects.

FIG. 7 illustrates a part of a medical package 144 according to afurther embodiment of the invention. The medical package 144 includes asheath 146 and a catheter product 148 located within the sheath 146. Aswith the embodiment of FIG. 1 and FIG. 2, the sheath 146 has an opening150 which is closed off by a lid (not shown) so that the sheath 146 andthe lid jointly define an enclosure for the catheter product 148.

The sheath 146 is initially a single component having first, second,third, and fourth walls 152, 154, 156, and 158 respectively with thefirst and second walls 152 and 154 opposing one another and the thirdand fourth walls 156 and 158 opposing one another. Breakable lines 160are formed in the first and second walls 152 and 154 and hinge lines 162(also shown in FIG. 13) are formed in the third and fourth walls 156 and158. The breakable lines 160 and the hinge lines 162 divide the sheath146 into a first, lower component 164, a second, upper component 166,and a third, upper component 168. It should be noted that the breakablelines 160 do not go through into the sheath 146, but are merely linesthat are formed on the sheath 146 to weaken the sheath 146 in selectedareas.

Once the lid is removed from the opening 150, the catheter product 148is still entirely located within the sheath 146. The second and thirdcomponents 166 and 168 can be pulled apart so that the sheath 146 breaksopen along the breakable lines 160 and the second and third componentshinge relative to the first component 164 at the hinge lines 162, asillustrated in FIG. 8. An upper portion of a body 170 of the catheterproduct 148 is then accessible while another portion (not shown) of thebody 170 is located within the first component 164 and is mountedthereto in a manner similar to the manner in which the body 40 ismounted to the sheath 20 as illustrated in FIG. 2. A person can thusgrip the upper portion of the body 170 and pull the catheter product 148out of the first component 164 of the sheath 146.

FIG. 9 illustrates a part of a medical package 10 according to yet afurther embodiment of the invention. The medical package 190 includes asheath 192, a lid (not shown), and a catheter product 194 located withinthe sheath 192. The sheath 192 has an opening 196 through which thecatheter product 194 is inserted into the sheath 192. The catheterproduct 194 is secured to the sheath 192 in a manner similar to themanner in which the catheter product 18 is secured to the sheath 20 asillustrated in FIG. 2 and the lid closes off the opening 196 and issecured thereto in a manner similar to the manner in which the lid 22closes off and is secured over the opening 24 as illustrated anddescribed with reference to FIG. 2.

The sheath 192 has first, second, third, and fourth walls 200, 202, 204,and 206, the first and second walls 200 and 202 opposing one another andthe third and fourth walls 204 and 206 opposing one another. The firstand second walls 200 and 202 each include a respective finger well 208and 210.

FIG. 10 is a cross-sectional view on 10—10 in FIG. 9 and FIG. 11 is across-sectional view on 11—11 in FIG. 9. FIG. 10 illustrates that thebody 212 is mounted between the third and fourth walls 204 and 206 in amanner similar to the manner in which the body 40 is mounted to thesheath 20 as illustrated and described with reference to FIG. 2. As moreparticularly shown in FIG. 11, a person can insert first and secondfingers into the finger wells 208 and 210 and the finger wells 208 and210 are open towards the body 212 of the catheter product 194 to allowfor gripping of the body 212 and subsequent removal of the catheterproduct 194 from the sheath 192.

FIG. 12 illustrates a medical package 230 according to yet a furtherembodiment of the invention. The medical package 230 includes a housing234 and a catheter product 236 located within the housing 234. As withthe previous embodiments, the housing 234 includes a sheath 238 and alid 240, and the catheter product 236 includes a body 242 and a needle244, the body 242 being mounted to the sheath.

The catheter product 236 has a center line 250 which substantiallycorresponds with a center line of the sheath 238. An opening 252 isformed into the sheath 238, with the lid 240 closing the opening 252.The opening 252 is formed so that the lid 240 is located at an angle ofabout 45° relative to the center line 250. When the lid 240 is pulledoff, a portion 254 of the body 242 is visible, or exposed when viewed ina direction 256 transverse to the center line 250. A person may thencontact the portion 254 of the body 242 on a side thereof which isexposed when viewed in the direction 256, and, using a single finger,may remove the catheter product 236 from the sheath 238. The portion 254may be roughened to increase fictional engagement between the portion254 and the finger of the person to facilitate removal of the catheterproduct 236 from the sheath 238.

FIG. 13 illustrates the medical package 14 of FIG. 7 in cross-sectionaldetail The housing 16 includes an elongate hollow sheath 20 and a lid22.

The sheath 20 has an opening 24 at the upper end thereof which providesaccess into the sheath 20. The sheath 20 is relatively large in a firstarea 28 near the opening 24, and relatively small in a second area 30 ona side of the first area 28 opposing the opening 24.

The sheath 20 has a plurality of retaining formations 32 extending froman inner surface thereof within the first area 28. Each retainingformation 32 includes first and second projections, 34 and 36respectively, with a gap 38 defined between the first and secondprojections 34 and 36.

The lid 22 is made of a breathable material which is sold under the name“TYVEK” by Dupont. The breathable material typically has pores which areabout 0.2 microns in diameter.

The catheter product 18 includes a body 40, an elongate vascular accessmember or needle 42, and a catheter assembly 43.

The body 40 has an annular engaging formation 44 extending from an outersurface thereof. The needle 42 has a first end 46 and a second, vascularentry end 48. The first end 46 is secured to the body 40 and second end48 is located distant from the body.

The catheter assembly 43 includes a hub 50, and a catheter 52. The firstend 54 of the catheter 52 is secured to the hub 50 and a second,opposing end 56 of the catheter 52 is located distant from the hub 50.The second end 45 of the needle 42 is inserted through the hub 50, andfrom the hub 50 through the catheter 52 until the second end 48 of theneedle 42 protrudes out of the second end 56 of the catheter 52.

The second end 48 of the needle 42 has a sharp tip which may be used forpiercing a vascular such as a vein or an artery. The catheter 52 and theneedle 42 are then inserted into the vascular. Fluid within the vascularpasses through the needle 42 into the body 40. The body 40 is usuallytransparent so that the fluid is visible through the body 40. The needle42 is then removed from the catheter 52 and another device such as asyringe or a pipe of a drip is connected to the hub 50. Fluids can bepassed between the other device and the vascular through the hub 50 andthe catheter 52.

The medical package 14 is assembled by first inserting the catheterproduct 18 through the opening 24 into the sheath 20. The needle 42 isinserted first into the sheath 20, followed by the body 40. The firstprojections 34 are spaced relative to one another more closely than anouter diameter of the engaging formation 44 so that the engagingformation 44 is brought into contact with sloped upper surfaces 58 ofthe first projections 34. When the catheter product 18 is furtherinserted into the sheath 20, the engaging formation 44 creates outwardforces acting on the sloped upper surfaces 58.

The sheath 20 is made of a flexible material such as polypropylene ornylon and, due to its materials and construction, flexes under the forcecreated by the engaging formation 44 so that the spacing between thefirst projections 34 widens. Once the spacing between the firstprojections 34 widens, the engaging formation 44 passes through thefirst projections 34 and comes to rest against the second projections36. Due to the flexibility of the sheath 20, the first projections 34then return to their original positions in a snapping action. Once thefirst projections 34 then return to their original positions, theengaging formation 44 is locked within the gaps 38.

By locking the engaging formation 44 within the gaps 38, the catheterproduct 18 is mounted to the sheath 20 and supported in a stationaryposition relative to the sheath 20. The catheter product 18 is entirelylocated in the sheath 20 and the sheath 20 is sufficiently strong toprotect the catheter product 18. The body 40 is located in the firstarea 28 of the sheath 20. The needle 42 is almost entirely located inthe second area 30 of the sheath 20 with the second end 48 and the sharptip 56 both displaced from an inner wall of the sheath 20.

A retaining shelf 60 is located on an inner sheath 20. The hub 50 has asurface on opposing sides thereof and the body 30 which rests on theshelf 60. The shelf 60 so prevents the catheter assembly 43 from movingoff the needle 42.

The lid 22 is then positioned so that it closes off the opening 24 andis then heated so that a periphery thereof seals circumferentially on aperiphery of the opening 24 and is attached to a periphery of theopening 24. The sheath 20 and the lid 22 so jointly define an enclosure62 which is sealed against ingress of contaminants.

Because of the porous nature of the lid 22, a sterilization fluid suchas ethylene oxide gas may be introduced into the enclosure 62 so thatthe confines of the enclosure 62 may be sterilized. The pores within thelid 22 are, however, generally too small for contaminants ormicroorganisms to pass through so that the confines of the enclosure 62remain sterile.

The housing 16 of FIG. 13 provides a rigid and sturdy enclosure whichentirely encloses the catheter product 18 and supports the catheterproduct 18. There is therefore no need for additional packaging such asblister packaging to seal the housing 16 against ingress ofcontaminants. The medical package 14 can thus be provided to a usersubstantially in the form shown in FIG. 13.

While certain exemplary embodiments have been described and shown in theaccompanying drawings, it is to be understood that such embodiments aremerely illustrative and not restrictive of the current invention, andthat this invention is not restricted to the specific constructions andarrangements shown and described, since modifications may occur to thoseordinarily skilled in the art.

What is claimed:
 1. A medical package which includes: a housing definingan enclosure which is sealed against ingress of contaminants, and havingat least a first part, and a second part which is movable relative tothe first part to open the enclosure at least one of the parts having aplurality of pores through which a sterilization fluid can enter theenclosure but which substantially prevent entry of contaminants into theenclosure; and a catheter product which includes: a body; and anelongate vascular access member having a first end and a second,vascular entry end, the first end being secured to the body and thesecond end being located distant from the body, the catheter productbeing located entirely within the enclosure, secured in position to thehousing and being removable from the housing after the second part ismoved relative to the first part to open the enclosure.
 2. The medicalpackage of claim 1 wherein the first part is a hollow sheath with anopening providing access into the sheath, the catheter product is atleast partially located within the sheath and is secured to the sheathinside the sheath, and the second part is a lid which closes off theopening.
 3. The medical package of claim 2 wherein the lid is attachedto a periphery of the opening and the attachment between the lid and theperiphery of the opening is at least partially breakable.
 4. The medicalpackage of claim 2 wherein the enclosure, where defined by the sheath,is relatively large in a first area near the opening and relativelysmall in a second area on a side of the first area opposing the opening,the body is secured to the sheath in the first area, and the elongatevascular access member is at least partially located in the second area.5. The medical package of claim 2 wherein the sheath has a retainingformation extending from an inner surface thereof, and the body has anengaging formation which engages with the retaining formation to supportthe catheter product in position.
 6. The medical package of claim 5wherein the retaining formation includes first and second projectionswith a gap defined between them, at least one of the projections beingmovable to the extent that it can give way under a force created by theengaging formation when the catheter product is inserted into thesheath, and at least partially return to its original position so as tolock the engaging formation in the gap.
 7. The medical package of claim5 wherein the sheath is at least partially made of a flexible material,and the retaining formation moves away from the engaging formation whenthe sheath is flexed, thereby disengaging the engaging formation fromthe retaining formation so as to allow for removal of the catheterproduct from the sheath.
 8. The medical package of claim 7 whichincludes finger tabs on opposing sides of the package sheath which, whencontacted by two respective fingers on a hand of a person, and movedrelative to one another by the fingers, cause movement of the retainingformation away from the engaging formation and disengagement of theengaging formation from the retaining formation.
 9. The medical packageof claim 8 wherein the retaining formation extends in a first selecteddirection from the inner surface, and, when the finger tabs are movedrelative to one another, the sheath is squeezed together transversely tothe first selected direction, causing the retaining formation to moveaway from the engaging formation in a second selected direction,opposing the first selected direction, and disengagement of the engagingformation from the retaining formation.
 10. The medical package of claim8 which includes flange portions extending from the sheath, and thefinger tabs are located on the flange portions.
 11. The medical packageof claim 10 wherein the flange portions pivot about first portions ofthe sheath and compress second portions of the sheath towards oneanother to cause elongation of at least part of the sheath in the secondselected direction.
 12. The medical package of claim 8 wherein at leasta first of the finger tabs pivots about a first portion of the sheath,and the retaining formation is located on a second portion of thesheath, on a side of the first portion approximately opposing the firstfinger tab, so that, when the first finger tab pivots about the firstportion in a first pivoting direction, the retaining formation alsopivots in the first pivoting direction about the first portion away fromthe engaging formation.
 13. The medical package of claim 12 wherein thesheath includes an additional retaining formation which engages with aretaining formation of the sheath, a second of the finger tabs pivotsabout a third portion of the sheath, and the additional retainingformation is located on a fourth portion of the sheath on a side of thethird portion approximately opposing the second finger tab so that, whenthe second finger tab pivots about the third portion in a secondpivoting direction, opposing the first pivoting direction, theadditional retaining formation also pivots in the second direction awayfrom the additional engaging formation.
 14. The medical package of claim13 wherein the sheath has a hinge portion between the retainingformations which, when the first finger tab pivots in the first pivotingdirection and the second finger tab pivots in the second pivotingdirection, assists in increasing an amount of rotation of the retainingformations relative to one another, resulting in more movement of therespective retaining formations away from the respective engagingformations.
 15. The medical package of claim 14 wherein the hingeportion is formed so as to create a stress concentration which causesmore flexing of the sheath.
 16. The medical package of claim 14 whereinthe hinge portion is a narrowing in the sheath.
 17. The medical packageof claim 5 wherein the opening has at least two finger wells, ondifferent sides of the catheter product, into which fingers on a hand ofa person are insertable, the finger wells being open towards thecatheter product to allow for gripping of the catheter product andsubsequent removal of the catheter product from the sheath.
 18. Themedical package of claim 5 wherein the sheath has first and secondopposed wall portions having edges which partially define the opening,and the lid closes off the opening, wherein the edges are shaped sothat, when the lid is at least partially moved to open the enclosure,there is a line of sight through the sheath between the wall portions ofthe sheath, the line of sight being at least partially blocked by thecatheter product.
 19. The medical package of claim 5 wherein the openingis formed so that, when the lid is at least partially moved to open theenclosure, a portion of the medical product is exposed when viewed in adirection at right angles to a center line of the medical product. 20.The medical package of claim 5 wherein the second part is a lid whichcloses the opening, the lid having a plurality of pores through which asterilization fluid can enter the enclosure.
 21. The medical package ofclaim 5 wherein the sheath has at least first and second componentswherein, when the lid is at least partially removed, the secondcomponent is movable relative to the first component to allow for betteraccess to the medical product.
 22. The medical package of claim 21wherein the retaining formation is located on an inner wall of thesheath, and the body has an engaging formation which engages with thefirst component wherein, when the second component is moved relative tothe first component to allow for better access to the medical product,the engaging formation is engaged with the retaining formation.
 23. Themedical package of claim 21 wherein the second component hinges relativeto the first component.
 24. The medical package of claim 23 wherein thesheath has at least a third component which hinges relative to the firstcomponent to allow for better access to the medical product.
 25. Themedical package of claim 1 wherein at least one of the parts has aplurality of pores through which a sterilization fluid can enter theenclosure.
 26. The medical package of claim 1 wherein the second end ofthe elongate vascular access member is displaced from an inner wall ofthe housing.
 27. The medical package of claim 1 wherein the elongatevascular access member has a sharp tip at the second end.
 28. Themedical package of claim 1 wherein the vascular access member is aneedle and the second end is a sharp tip of the needle, the medicalpackage further including: a catheter assembly comprising: a hub; and acatheter having a first end secured to the hub and a second end locateddistant from the hub, the hub and the catheter being located over theneedle with the catheter located on a side of the hub opposing the body,the housing further having a shelf on an inner surface thereof, theshelf supporting the hub on a surface thereof opposing the body.
 29. Amedical package which includes: a housing defining an enclosure which issealed against ingress of contaminants, and having a hollow elongatesheath with an end having an opening into the sheath, and a lid whichcloses the opening and seals with a periphery of the opening; a catheterproduct including: a body; and an elongate vascular access member havinga first end and a second, vascular entry end, the first end beingsecured to the body and the second end being located distant from thebody, the catheter product being located entirely within the sheath. 30.A medical package which includes: a housing defining an enclosure whichis sealed against ingress of contaminants, the housing including atleast: a flexible first part having a retaining formation extending froman inner surface thereof; and a second part which is movable relative tothe first part to open the enclosure; and a catheter product including:a body having an engaging formation thereon; an elongate vascular accessmember having a first end and a second, vascular entry end, the firstend being secured to the body and the second end being located distantfrom the body, the catheter product being located entirely within theenclosure, secured in position to the housing by interengagement of theengaging formation with the retaining formation, wherein flexing of thefirst part causes disengagement of the engaging formation from theretaining formation to allow for removal of the catheter product fromthe housing after the second part is moved relative to the first part toopen the enclosure.
 31. A method of packaging a catheter productcomprising: locating the catheter product within a housing which definesan enclosure which is sealed against ingress of dirt so that the medicalproduct is located entirely within the enclosure, the housing includingat least one part having a plurality of pores through which asterilization fluid can enter the enclosure, but which substantiallyprevent entry of contaminants into the enclosure, the medical producthaving a body secured in position to the housing, and an elongatevascular access member having a first end and a second, vascular entryend, the first end being secured to the body and the second end beinglocated distant from the body in a position which is displaced from aninner wall of the housing.